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Press Releases From the FDA / FDA acts to bolster supply of critically needed cancer drugs
« Last post by recalls-bot on Yesterday at 11:03:51 AM »
FDA acts to bolster supply of critically needed cancer drugs
21 February 2012, 9:18 am

The U.S. Food and Drug Administration today announced a series of steps to increase the supply of critically needed cancer drugs and build on President Obama’s Executive Order to help prevent future drug shortages.

Source: Food and Drug Administration--Press Releases

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Press Releases From the FDA / FDA approves Korlym for patients with endogenous Cushing’s syndrome
« Last post by recalls-bot on February 17, 2012, 05:25:11 PM »
FDA approves Korlym for patients with endogenous Cushing’s syndrome
17 February 2012, 3:08 pm

Today, Korlym (mifepristone) was approved by the U.S. Food and Drug Administration to control high blood sugar levels (hyperglycemia) in adults with endogenous Cushing’s syndrome. This drug was approved for use in patients with endogenous Cushing’s syndrome who have type 2 diabetes or glucose intolerance and are not candidates for surgery or who have not responded to prior surgery. Korlym should never be used (contraindicated) by pregnant women.

Source: Food and Drug Administration--Press Releases

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Press Releases From the FDA / FDA approves Zioptan to treat elevated eye pressure
« Last post by recalls-bot on February 14, 2012, 05:00:22 PM »
FDA approves Zioptan to treat elevated eye pressure
14 February 2012, 4:54 pm

On February 10, the U.S. Food and Drug Administration approved Zioptan (tafluprost ophthalmic solution) to help reduce elevated eye pressure in people with open-angle glaucoma.

Source: Food and Drug Administration--Press Releases

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Press Releases From the FDA / FDA seeks $4.5 billion to support medical product development, protect patients and ensure safety of the food supply
« Last post by recalls-bot on February 13, 2012, 05:13:55 PM »
FDA seeks $4.5 billion to support medical product development, protect patients and ensure safety of the food supply
13 February 2012, 1:00 pm

The U.S. Food and Drug Administration is requesting a budget of $4.5 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2013 budget – a 17 percent increase over the FDA enacted budget for FY 2012. Industry user fees would fund 98 percent of the proposed budget increase. The FY 2013 request covers the period from Oct. 1, 2012 through Sept 30, 2013.

Source: Food and Drug Administration--Press Releases

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Press Releases From the FDA / New Jersey company agrees to halt production of unapproved dental devices
« Last post by recalls-bot on February 13, 2012, 11:02:09 AM »
New Jersey company agrees to halt production of unapproved dental devices
13 February 2012, 10:26 am

Accurate Set Inc., of Newark, N.J., and the company’s president and owner, Cornell L. Adams, have agreed to stop manufacturing and distributing medical devices as part of a consent decree of permanent injunction.

Source: Food and Drug Administration--Press Releases

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Press Releases From the FDA / FDA investigating illegal online sale of handheld dental X-ray units
« Last post by recalls-bot on February 10, 2012, 01:36:37 PM »
FDA investigating illegal online sale of handheld dental X-ray units
10 February 2012, 9:16 am

The U.S Food and Drug Administration is warning dental and veterinary professionals to not purchase or use certain potentially unsafe hand-held dental X-ray units. The FDA is concerned that these devices may not be safe or effective and could expose the user and the patient to unnecessary and potentially harmful X-rays. The units, sold online by manufacturers outside the United States and directly shipped to U.S. customers, have not been reviewed by the FDA and do not meet FDA radiation safety requirements. (MB)

Source: Food and Drug Administration--Press Releases

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Press Releases From the FDA / FDA issues draft guidance on biosimilar product development
« Last post by recalls-bot on February 09, 2012, 05:11:07 PM »
FDA issues draft guidance on biosimilar product development
9 February 2012, 11:22 am

The U.S. Food and Drug Administration today issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.

Source: Food and Drug Administration--Press Releases

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Press Releases From the FDA / FDA and industry reach agreement in principle on medical device user fees
« Last post by recalls-bot on February 01, 2012, 11:02:09 AM »
FDA and industry reach agreement in principle on medical device user fees
1 February 2012, 8:48 am

The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program. The recommendations would authorize the FDA to collect $595 million in user fees over five years, plus adjustments for inflation. Details of the agreement, such as the fee structure, are expected to be finalized soon.

Source: Food and Drug Administration--Press Releases

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Press Releases From the FDA / FDA approves Gleevec for expanded use in patients with rare gastrointestinal cancer
« Last post by recalls-bot on January 31, 2012, 11:34:44 PM »
FDA approves Gleevec for expanded use in patients with rare gastrointestinal cancer
31 January 2012, 4:29 pm

The U.S. Food and Drug Administration today granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today’s action also highlights an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment.

Source: Food and Drug Administration--Press Releases

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Press Releases From the FDA / FDA approves Kalydeco to treat rare form of cystic fibrosis
« Last post by recalls-bot on January 31, 2012, 05:33:15 PM »
FDA approves Kalydeco to treat rare form of cystic fibrosis
31 January 2012, 9:59 am

The U.S. Food and Drug Administration today approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene.

Source: Food and Drug Administration--Press Releases

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